Authors
Latest:
Stability Testing in BiopharmaThree case studies illustrate some analytical methods important for stability testing.
Latest:
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific ReproducibilityRafe Swan/Getty Images; Dan WardIrreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays a
Latest:
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific ReproducibilityRafe Swan/Getty Images; Dan WardIrreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays a
Latest:
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific ReproducibilityRafe Swan/Getty Images; Dan WardIrreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays a
Latest:
Temperature and Relative Humidity Control to Reduce Bioburden in a Closed Cell Processing and Production System without DisinfectantsControlling certain atmospheric conditions in a closed NGI processing chamber can reduce bioburden without disinfectants.
Latest:
Best Practices in Qualification of Single-Use SystemsThe author discusses the current best practices in technical qualification of single-use systems.
Latest:
Feasibility of a Rapid Microbiological Method for Filterable Raw MaterialsThe rapid microbiological growth-based method represents an alternative for the quantification of contaminants in filterable products.
Latest:
Feasibility of a Rapid Microbiological Method for Filterable Raw MaterialsThe rapid microbiological growth-based method represents an alternative for the quantification of contaminants in filterable products.
Latest:
Connecting People, Science, and RegulationPDA/FDA regulatory conference promotes a commitment to quality.
Latest:
Data Integrity: Getting Back to BasicsEnsuring data integrity involves effort on an individual and global basis.
Latest:
Guidance on Quality Culture StandardsMatt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
Latest:
Defining Risk Assessment of Aseptic ProcessesSusan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
Latest:
Utilizing Run Rules for Effective Monitoring in ManufacturingSorendls/Getty ImagesTo maintain a state of control and comply with regulatory authorities, many pharmaceutical, biotech, and medical-device companies have adopted continued pro
Latest:
Innovations in Automation—High-Throughput Dynamic Light Scattering for Screening Biotherapeutic FormulationsThis article introduces the technology that powers automated HT–DLS and explores its practical applications in enhancing formulation stability investigations.
Latest:
The Benefits of Combining UHPLC-UV and MS for Peptide Impurity ProfilingDetermining a peptide’s purity is challenging because impurities are often structurally similar to each other and the API and can be present at very low concentrations. New approaches offer a solution.
Latest:
A Risk-Based Strategy for Implementing Disposables in a Commercial Manufacturing ProcessThe author explores a dual-supplier sourcing strategy for single-use products and its ability to mitigate business continuity risk.
Latest:
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody ActivitySurface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics.
Latest:
Evolving to Meet Industry ChangesIn the development of biopharmaceuticals and pharmaceuticals, the line is blurring.
Latest:
Analysis of PEGylated Protein by Tetra Detection Size Exclusion ChromatographyReliably detecting low amounts of high molecular weight impurities during process development and characterization of biopharmaceutical products.
Latest:
Top Three Factors That Will Drive Biopharma in the FutureDespite the unpredictability of biopharma, key forces promise to shape the market over the next few years
Latest:
Nontuberculosis Mycobacterium Contamination of a Mammalian Cell Bioreactor ProcessThe authors present a case study identifying a contaminant.
Latest:
Are Biopharma Patents Poised on the Post-Grant Chopping Block?This article examines trends in biopharma post-grant patent review and projects what the future holds in store.
